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Allantoin

Well toleratedActivesoothingskin protectingskin conditioning

No meaningful concern for most people; irritation is possible but rare.

Also written as: Comfrey extract derivative

What it is

Allantoin is a small molecule originally isolated from comfrey root, though the cosmetic ingredient is made synthetically and is chemically identical. It is classed as a skin-protecting and soothing agent, and is one of the least irritating ingredients in common use. Formulators add it at low levels - usually well under 1% - to take the edge off actives like acids and retinoids.

What it does well

  • Reduces the sting and roughness of irritated skin

    Allantoin is a recognised skin protectant with a long record of safe use, and appears in many formulas specifically to improve tolerability. Most evidence comes from finished-product studies where it is one of several soothing ingredients.

    Moderate evidence

  • Extremely low irritation and allergy risk

    Allantoin is among the best-tolerated cosmetic ingredients; allergic contact dermatitis to it is very rare. It is widely used in products for babies, sensitive skin and post-procedure care.

    Strong evidence

Worth knowing

  • Benefits are supportive, not transformative

    A phase 3 randomised, double-blind, vehicle-controlled trial of 6% allantoin cream in epidermolysis bullosa failed its primary endpoint, showing no significant advantage over the vehicle for wound closure. Allantoin makes formulas more comfortable; it does not act as a strong healing drug.

    Matters most toAnyone choosing a product mainly for an advertised allantoin "repair" claim.

Where the EU stands

No specific restriction

No EU concentration limit or annex restriction. Note that the unrelated complex Allantoin PABA is banned under Annex II, but plain allantoin is not affected.

source ↗

Sources (1)

Every link goes to the original: a journal, a PubMed record or an EU document.

  1. [1]
    Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)

    Orphanet Journal of Rare Diseases · 2020 · doi:10.1186/s13023-020-01419-3

    The trial failed its primary endpoint - 6% allantoin cream showed no significant advantage over vehicle for time to wound closure - while remaining well tolerated.

Masks that contain Allantoin